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Terminated

Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

FDA Recall Z-1282-2019 · Posted None

Recalling FirmMedtronic Inc.
Recall StatusTerminated
Product CodeMDS
Date Initiated2018-07-04
Date Terminated2022-06-06
Product QuantityApproximately 9,328 registered users

Reason for Recall

The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.

Firm Action

A Field Corrective Action was initiated outside of the U.S. by the recalling firm's global regions on 7/4/2018.

Root Cause

Software design

Distribution Pattern

Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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